Evaluation of prescribing pattern of phosphodiesterase-5 inhibitors and assessing effectiveness of sildenafil and tadalafil in patients with erectile dysfunction

Several factors may affect identification and treatment of erectile dysfunction by health care providers, this study evaluates prescribing pattern of PDE-5 inhibitors and assess effectiveness of Sildenafil and Tadalafil in patients with erectile dysfunction.This is a descriptive and observational study, observed participants without providing any interventions, after fulfilling inclusion and exclusion criteria, patients were enrolled into study and informed written consent was obtained from all patients, data was obtained from medical records, analysed descriptively. International Index of Erectile Function (IIEF) Questionnaire is used in assessment of erectile dysfunction and treatment outcomes.In our study, 80% of patients were prescribed with phosphodiesterase inhibitors and 20% received nutritional supplements. 80 percent of drugs were prescribed under generic name, subjects treated with Sildenafil/Tadalafil were found to be associated with higher mean scores for questions of International Index of Erectile Function (IIEF). Tadalafil scored high in terms of sexual desire domain.PDE5 inhibitors represent major first-line oral therapy option for men with erectile dysfunction, shift of market from brand to generic products allows more freedom of choice, although multiple reports suggest general equivalency of four major PDE5 inhibitors, tadalafil suggested to be preferable.

Assessment of Knowledge, Attitudes, and Factors Influencing the Selection Student of Generic Medicine

Background: Generic replacements for branded medicines have become a typical practice among registered pharmacists all over the world. Therefore, this study was aimed to determine the influence of the knowledge and attitudes of PharmD students and other factors on the selection of unbranded medicines.Methods: A descriptive, cross-sectional study was conducted through Google Forms to collect data using self-reported questionnaires. The data was collected over a period of 3 months, from January to March 2021, among junior level pharmacy students who are currently undertaking a PharmD course at the King Saud University, College of Pharmacy, Riyadh, Saudi Arabia.Results: The mean age of the students was 21.05± (SD = 1.03), majority of students 70.2% (n = 134) were able to define the term generic medicine, and about 65% (n = 123) were able to correctly define bioequivalence. More than half of the students, 56.5% (n = 108) lacked knowledge about the pharmacokinetic parameters of generic products. Meanwhile, the majority, 85% (n = 122), supported generics over branded medicines, and about 66% (n = 99) agreed that wider use of generic medicines would lead to less money required for the research and development of new pharmaceuticals.Conclusion: Findings revealed that most pharmacy students possess sufficient knowledge of generic medicines, although knowledge in some aspects remains lacking.

Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

Comparison of generic and proprietary aquatic herbicides for control of invasive vegetation; part 3 : submersed plants

Herbicide selection is key to efficiently managing nuisance vegetation in our nation’s waterways. After selecting the active ingredient, there still remains multiple proprietary and generic products to choose from. Recent small-scale research has been conducted to compare the efficacy of these herbicides against floating and emergent species. Therefore, a series of mesocosm and growth chamber trials were conducted to evaluate subsurface applications of the following herbicides against submersed plants: diquat versus coontail (Ceratophyllum demersum L.), hydrilla (Hydrilla verticillata L.f. Royle), southern naiad (Najas guadalupensis (Sprengel) Magnus), and Eurasian watermilfoil (Myriophyllum spicatum L.); flumioxazin versus coontail, hydrilla, and Eurasian watermilfoil; and triclopyr against Eurasian watermilfoil. All active ingredients were applied at concentrations commonly used to manage these species in public waters. Visually, all herbicides within a particular active ingredient performed similarly with regard to the onset and severity of injury symptoms throughout the trials. All trials, except diquat versus Eurasian watermilfoil, resulted in no differences in efficacy among the 14 proprietary and generic herbicides tested, and all herbicides provided 43%–100% control, regardless of active ingredient and trial. Under mesocosm and growth chamber conditions, the majority of the generic and proprietary herbicides evaluated against submersed plants provided similar control.

PREVALENCE OF THE USE AND SOCIAL ACCEPTANCE OF GENERIC DRUGS IN THE MUNICIPALITY OF ITUMBIARA-GO

The objective of this study was to point out the prevalence of generic drug use and popular acceptance in the municipality of Itumbiara-GO, besides presenting the relationship between cost and benefit, efficacy and factors that influence user acceptance. The study consisted of a bibliographic and field study, through the application of a quantitative methodology, through a structured questionnaire that was applied and a group of 50 randomly selected people. It was verified that most of the group of interviewees has knowledge about generic drugs, as well as their low costs; but reported that they receive information from unreliable sources, which state that the generic medication does not have the same efficacy as a reference drug. The research also related that public policy actions development lives by the Ministry of Health and health professionals are mental foundations for the popularization of generic products. It was possible to conclude that the actions of dissemination and education by health agencies should be continuous, since they have the purpose of informing the community and thus, contributing to the promotion of health, especially, of the low-income population.,

Quality Attributes Comparison of Selected Brands of Rosuvastatin Calcium Tablets Marketed in the US and Bangladesh

Aims: This study investigated whether locally marketed rosuvastatin calcium tablets in Bangladesh have comparable physical and chemical attributes, including in vitro bioequivalence profiles, to the proprietary brand. Methodology: Nine generic products (G1-G9) containing 10 mg of rosuvastatin calcium were compared to the proprietary brand Crestor® (R1) and an FDA approved generic rosuvastatin calcium tablet (R2). Weight variation, diameter, thickness, friability, drug content, disintegration time and dissolution profiles were tested according to United States Pharmacopeia (USP) guidelines. In vitro bioequivalence requirements were assessed by calculating difference (f1) and similarity (f2) factors. Results: The generic products complied with the pharmacopeial requirements for weight variation, disintegration time and friability. All the tablets had drug ranging between 92%-105% and released more than 80% of rosuvastatin within first 15-30 minutes. However, for brands G5, G7 and G8 the f1 values were 15.7%, 15.82% and 25.21% respectively and their f2 values were 41.8, 41.6 and 32.6 respectively whereas for G9 the f2 value was 43.4. These brands have thus failed to meet in vitro bioequivalence requirements. Conclusion: We conclude that few substandard generics of rosuvastatin calcium has somehow found its way to the market and further studies are required to ascertain their noncompliance.

South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices that have been implemented by SAHPRA to support the assessment of new chemical entities and generic product applications for market authorization in the business-as-usual and backlog process streams.Methods: A questionnaire was completed and verified by SAHPRA to describe the structure of the organization, the resources available, the process for regulatory review of new chemical entities and generic products and the level of implementation of good review practices and regulatory decision-making practices for market authorization. Data were collected and analyzed on the overall approval timelines for new chemical entities and generic products registered by SAHPRA in 2020 in the business-as-usual and backlog process streams.Results: A full, independent scientific review was conducted for all new chemical entities and generic product applications in the business-as-usual stream. Facilitated regulatory pathways were introduced for the review of new chemical entities and generic products in the backlog stream. As a result, the timelines for approval of applications in the backlog stream were 68% quicker for both new chemical entities and generics, using facilitated regulatory pathways, such as abridged and verification review models.Conclusion: The comparisons made through this study provided insight into the improvements that have been made through the establishment of SAHPRA and the transition in 2018 from the MCC. The re-engineered processes that have been developed and implemented by SAHPRA to address the backlog in the review of the applications for market authorization have demonstrated a decrease in the overall median approval times. The expansion of these processes into the routine review of medical products will contribute to the enhanced regulatory performance of SAHPRA and patients’ access to new medicines.

FDA's drug regulatory pathways, its development strategies and regulatory considerations

People who are interested in drug development may be aware that New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) are 2 of the FDA's regulatory pathways for how prescription drugs can be approved and ultimately reach the market. In basic terms, NDAs are for new drugs that have not yet been approved and ANDAs are for generic products. NDA, also called 505 (b)(1), is the format that manufacturers use to bring a formal proposal to the FDA that a new drug should be approved and made available for use by patients in the United States. Under 505(b)(1), all investigations supporting safety and effectiveness, both clinical and nonclinical, are conducted by or on behalf of the sponsor. The other pathway is termed as abbreviated because preclinical and clinical trials are not required. The abbreviated approval pathways are described in section 505(j) and 505(b)(2) of the FD&C Act and known as ANDA and Hybrid applications respectively. Hatch-Waxman amendments in 1984 provided for a suitability petition that allows the application of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient). The differences allowed for suitability petition and 505(b)(2) application are same but ANDA filed through suitability petition can contain only those differences that do not need clinical evidence for efficacy and safety. This article identifies considerations to help potential applicants determine the appropriate submission pathway, its development strategies to support approval under those pathways.

PREVALENCE OF THE USE AND SOCIAL ACCEPTANCE OF GENERIC DRUGS IN THE MUNICIPALITY OF ITUMBIARA-GO

The objective of this study was to point out the prevalence of generic drug use and popular acceptance in the municipality of Itumbiara-GO, besides presenting the relationship between cost and benefit, efficacy and factors that influence user acceptance. The study consisted of a bibliographic and field study, through the application of a quantitative methodology, through a structured questionnaire that was applied and a group of 50 randomly selected people. It was verified that most of the group of interviewees has knowledge about generic drugs, as well as their low costs; but reported that they receive information from unreliable sources, which state that the generic medication does not have the same efficacy as a reference drug. The research also related that public policy actions development lives by the Ministry of Health and health professionals are mental foundations for the popularization of generic products. It was possible to conclude that the actions of dissemination and education by health agencies should be continuous, since they have the purpose of informing the community and thus, contributing to the promotion of health, especially, of the low-income population.,